Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

May 28, 2014 updated by: Zhejiang Hisun Pharmaceutical Co. Ltd.
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Public Health Clinical Center Affiliated to Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. from 18-65 years old
  2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
  3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion Criteria:

  1. liver mass, liver carcinoma
  2. liver failure
  3. non-hepatic diseases caused jaundice
  4. obstructive jaundice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ademetionine 1
Ademetionine 2000mg
Drug: Ademetionine 1
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Experimental: Ademetionine 2
Ademetionine 1000mg
Drug: Ademetionine 2
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
Active Comparator: Ademetionine 3
no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Drug: Ademetionine 3
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of serum total bilirubin declined from baseline
Time Frame: 2 weeks
levels of serum total bilirubin declined from baseline
2 weeks
Alkaline Phosphatase
Time Frame: 10 weeks
Alkaline Phosphatase
10 weeks
Gamma-Glutamyl Transpeptidase
Time Frame: 10 weeks
Gamma-Glutamyl Transpeptidase
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of serum direct bilirubin decline from baseline
Time Frame: 2 weeks, 6 weeks, 10 weeks
level of serum direct bilirubin decline from baseline
2 weeks, 6 weeks, 10 weeks
level of serum bile acids decline from baseline
Time Frame: 2 weeks, 6 weeks, 10 weeks
level of serum bile acids decline from baseline
2 weeks, 6 weeks, 10 weeks
glutamic pyruvic transaminase
Time Frame: 2 weeks, 6 weeks, 10 weeks
glutamic pyruvic transaminase
2 weeks, 6 weeks, 10 weeks
glutamic oxaloacetic transaminase
Time Frame: 2 weeks, 6 weeks, 10 weeks
glutamic oxaloacetic transaminase
2 weeks, 6 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Investigators

  • Principal Investigator: Liang Chen, Public Health Clinical Center Affiliated to Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (Estimate)

December 2, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMX-HBV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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